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NCT02553915 · ClinicalTrials.gov registry record · Phase 2
Omega-3 Fatty Acids for Major Depressive Disorder With High Inflammation: A Personalized Approach
A Phase 2 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 61
- Enrollment target
NCT02553915: Completed Phase 2 study, sponsored by Massachusetts General Hospital.
NCT02553915 is a Phase 2 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 61 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02553915, a Phase 2 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 61 participants
- Enrollment target
Study Summary
This project aims to evaluate whether a dose-response relationship exists between dose of polyunsaturated fatty acids (PUFA), delivered as eicosapentaenoic acid (EPA), and change in markers of inflammation, and whether these effects differ from placebo. A key secondary aim is to evaluate the antidepressant effectiveness of EPA in overweight adult outpatients with current major depressive disorder (MDD). To address these aims, the project will use a four-arm, randomized, parallel-group, placebo-controlled design comparing placebo versus three doses of EPA (1 gm/day, 2 gm/day, or 4 gm/day) administered over 12 weeks. The study is to be conducted at two sites: Emory University School of Medicine, and Massachusetts General Hospital. Eligible participants will be between the ages of 18-80 who have current MDD, are overweight, and who demonstrate peripheral inflammation, defined as an high sensitivity C-reactive protein (hs-CRP) level ≥ 3 mg/L. The primary outcome will be change in plasma interleukin-6 (IL-6) levels and/or mitogen-stimulated peripheral blood mononuclear cells (PBMC) Tumor Necrosis Factor-alpha (TNF-α) expression levels in EPA- versus placebo-treated participants. The results of this investigation are intended to be used to design and power a larger definitive test of the efficacy and biological effects of EPA in patients with major depressive disorder.
Primary Outcome
To evaluate whether a dose-response relationship exists between dose of EPA and decrease either in plasma interleukin-6 (IL-6) levels (pg/mL) or in mitogen-stimulated peripheral blood mononuclear cell (PBMC) Tumor Necrosis Factor-α (TNF-α) expression and secretion (pg/mL), when compared with placebo. Levels of inflammatory biomarkers were assessed at baseline (week 0) and at week 12 for comparison. Percent changes were calculated as relative to baseline values. Greater percent decrease indicates
Interventions
- OTHER Placebo
- DRUG EPA 1 g/day
- DRUG EPA 2 g/day
- DRUG EPA 4 g/day
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2015-12 |
| Est. Completion | 2022-03-31 |
| Phase | Phase 2 |
What the finished NCT02553915 record still lists
NCT02553915 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02553915 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02553915 about?
NCT02553915 is a clinical study titled "Omega-3 Fatty Acids for Major Depressive Disorder With High Inflammation: A Personalized Approach". This project aims to evaluate whether a dose-response relationship exists between dose of polyunsaturated fatty acids (PUFA), delivered as eicosapentaenoic acid (EPA), and change in markers of inflammation, and whether these effects differ from placebo. A key secondary aim is to evaluate the antidep...
What is the current status of trial NCT02553915?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 61 participants. The study started on 2015-12. Estimated completion is 2022-03-31.
What interventions are being tested in trial NCT02553915?
The interventions under investigation include: Placebo (OTHER), EPA 1 g/day (DRUG), EPA 2 g/day (DRUG), EPA 4 g/day (DRUG).
Who is sponsoring clinical trial NCT02553915?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02553915's enrollment target sits among peer trials
61 1026th of 2000 higher than 974 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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